FDA advisers skeptical on Teva Parkinson’s drug

Advisers to the Food and Drug Administration, following the note struck by FDA researchers last week, voted unanimously to say that data from Teva’s latest trial were unconvincing of Azilect’s ability to delay the clinical progression of Parkinson’s.Azilect, generically known as rasagiline and already approved as a Parkinson’s therapy, is the first drug to seek FDA’s approval as a medicine that affects the course of the neurogenetic disorder instead of merely masking its symptoms.”This is really going to be the flagship… and we have to be very solid in this and set a very high standard,” said Dr. Robert Clancy, one of the panel members and a neurology professor at the Children’s Hospital of Philadelphia.”If we’re wishy-washy with this, then the next thing that comes around is going to be expecting that being close is good enough. And this is close, but it’s not good enough.”Azilect, which Israel-based Teva markets alongside Danish partner Lundbeck in several countries, already has FDA approval to treat symptoms of the neurological disorder, such as trembling limbs, stiffness, slow movement and impaired balance. Teva is seeking an expansion of Azilect’s label.In Teva’s latest trial, Parkinson’s appeared to deteriorate more slowly in patients who started taking Azilect earlier than in those who began later. But while the 1 milligram (mg) dose appeared to slow the progression, the 2 mg dose did not, overshadowing the results of the 1 mg trial under review.

Euro zone crisis set to dominate G20 meeting in Paris

* Bigger goals, such as bank rules, set for G20 Nov. summit in CannesBy Catherine Bremer and Daniel FlynnPARIS, Oct 14 (Reuters) - G20 finance chiefs and central bank heads meet in Paris on Friday urgently needing to find a convincing solution to a deepening euro zone debt crisis that has fanned fears of a global slide into recession.A source at the French finance ministry — which is battling to flesh out the bones of a crisis resolution plan with Germany in time for an Oct. 23 European Union summit — said the euro zone was more pressing than anything else on the two-day agenda.”This meeting takes place in a context where the absolute priority for the success of the G20 is to find the elements for the stability of the euro zone,” the source said.With impatience growing over the crisis, and its implications for the rest of the world, finance chiefs from outside the bloc are expected to speak frankly.”This meeting is an important staging point before (a G20 summit in) Cannes and a valuable opportunity to put pressure on the euro zone,” said a non-euro zone G20 delegate.Canadian Finance Minister Jim Flaherty set the tone late on Thursday, telling reporters before leaving Ottawa that euro zone actions were short of what is needed.Unlike in 2009 when the G20 launched a coordinated stimulus to pull the world out of economic crisis, the forum is at risk of division as the rest of the world chafes at Europe’s dithering over a debt crisis that started 18 months ago in Greece, and as Washington and Beijing spar over the yuan.Paris and Berlin are taking time to agree on how to recapitalise banks and while Germany favours a second round of losses for Greek bondholders, Paris is reticent. The two euro heavyweights also differ on the idea of joint bond issuance for the euro zone, with Germany loath to see its debt costs rise.The Franco-German crisis plan is likely to ask banks to accept big losses on their Greek debt and should lay out a system for recapitalising troubled banks, whose shares have been pounded by fears about Greek exposure.At its core will be an agreement on how to increase the firepower of the EFSF rescue fund, and it should also set out a timeframe for ramping up economic coordination, with closer governance and explicit national laws on balancing budgets.The G20 may refer to the euro crisis in its communique and in closing news conferences on Saturday evening, but little else of substance is likely to be inked in.CHINA MAY OFFER GROWTH, NO YUAN SHIFTThis week’s talks may give the green light to regulators for new rules on banks deemed ‘too big to fail’, including capital surcharges, due to be officially approved in Cannes.Yet any concrete progress on bigger goals such as setting parameters to measure global imbalances and reining in commodity market volatility and speculative capital flows is unlikely to come before a Nov. 3-4 summit in Cannes, where France passes the G20 baton to Mexico.The finance ministry source said that for Cannes France hoped to have two or three measures agreed for countries showing imbalances: consolidation measures for those with high deficits and stimulus measures for those with surpluses.”We are going to try to make some progress and obtain, perhaps not tomorrow or Saturday but by Cannes, a list of measures country by country which corresponds to what is needed to relaunch global economic activity,” he said. “These must be measures which will have an impact on the real economy.”A separate G20 source said after preparatory talks late on Thursday that China would commit in Paris to boost its consumption through a five-year plan, via households and companies as well as infrastructure, as the G20 seeks tough fiscal commitments from the euro zone and the United States.The G20 countries make up 85 percent of global output.An April G20 meeting placed seven large economies under review — the debt-burdened United States, export-rich China, France, Britain, Germany, Japan and India. Officials have said privately the aim was to get Beijing to discuss the yuan, and China’s cooperation is essential to the success of the process.France has dangled the prospect of the yuan entering the basket of currencies making up the IMF’s Special Drawing Right (SDR) in a bid to divert the debate away from its value and onto the criteria of free “usability” required for this.The euro zone crisis has derailed Sarkozy’s hopes of using his G20 presidency to launch a fundamental rethink of the global financial system and its reliance on the U.S. dollar.China and the United States sparred this week over a U.S. Senate bill to press Beijing to raise the yuan’s value, and the issue is likely to create a sideshow at the G20 talks, even if the euro zone crisis pushes it off centre stage.”China won’t play a big role at the meeting,” said He Fan, deputy head of the Institute of World Economics & Politics at the Chinese Academy of Social Sciences government think tank.”China cannot do much over the European debt crisis. China will not buy European bonds on a large scale. There are not many choices out there. Italy is the biggest bond issuer in Europe, but I doubt China will buy its bonds. The question for China is how to safeguard its investment in Europe,” He said.He added that China could participate in a multilateral framework for rescuing European banks, such as via the IMF.A G20 official told Reuters on his way out of talks on Thursday that China and Japan were both open to lending more funds to the IMF to help with the euro zone crisis.Two other sources said several BRICS countries, notably India, China and Brazil, favoured bolstering the IMF’s capital as a way to contribute to a rescue for Greece, but without altering voting rights in the lender.Brazilian Finance Minister Guido Mantega also said this week that extra IMF support may be debated.

Carlyle, Cerberus, Platinum eye Cooper Standard: sources

Cooper Standard, which has hired JPMorgan Chase (JPM.N) and Lazard Ltd (LAZ.N) to explore a sale, is in the second round of the auction, which has been moving slowly in a volatile financing market, one of the people said.While financing remains relatively cheap for companies with strong credit ratings, buyout deals typically need leveraged loans and high-yield bonds — the riskier form of lending that carries some of the highest interest rates and often is the first financing to be withdrawn when credit tightens.Wall Street banks are becoming more selective about what financing deals they commit to or stiffening lending terms, making buyout deals like Cooper Standard more costly for buyers and therefore limiting their ability to pay.The company emerged from bankruptcy in May of 2010 under the control of a handful of hedge funds, including Silver Point Capital and Oak Hill Advisors. The Novi, Michigan-based company, which makes body sealing systems and fluid handling systems for the automotive industry, could be valued at more than $1.5 billion, several people told Reuters previously.Meanwhile, Carlyle is also bidding for another auto parts supplier TI Automotive, which competes with Cooper Standard in the fluid system segment and has been considering a sale since early this year, people familiar with the matter said on September 29. Bain Capital and London-based buyout firm Pamplona Capital Management are the other remaining bidders for TI Automotive, the people said at that time.TI Automotive and Cooper Standard are the world’s two largest suppliers of systems that control, sense and deliver fluids and vapors in vehicles. But TI has greater exposure to the fast-growing Asian markets, drawing roughly a quarter of its revenue from China and other Asian markets.Representatives for Carlyle, Cerberus and Platinum Equity all declined to comment. Cooper was not immediately available for comment.

Root beer, roast beef, fish & chips: Who’s buying?

There’s a new batch of quick-service restaurants on the block – Arby’s, A&W and Long John Silver’s – and according to YouGov BrandIndex, A&W is the most popular of the three. A&W, founded in 1919 and known for its root beer, had the trio’s highest satisfaction rates, said YouGov BrandIndex, which does daily consumer perception research on brands.  A&W and Arby’s had higher satisfaction scores than an average of about two dozen fast-food chains, while Long John Silver’s fared worse. (See graphic below) “A&W and Arby’s have a core group of supporters and satisfied customers,” said Ted Marzilli, global managing director for YouGov BrandIndex. “If I’m a buyer, that’s a strength.” Marzilli predicted that all three brands would find buyers, although prices and other terms likely would differ. He said A&W and Arby’s could be reinvigorated by buyers who focused on their strengths, while Long John Silver’s is more of a turnaround story. Another big question is whether any of the chains will snag a valuation as rich as the one attached to Burger King’s $3.3 billion sale to 3G Capital last year.  The $24 per share sale price represented a 46 percent premium to Burger King’s price before news of the negotiations emerged. When asked how Burger King satisfaction scores looked, Marzilli said they were ”a hair higher” than Arby’s over the last six months.